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FDA 510(k)

IPS CaseDesigner

K-Number: K161634 · 2016-11-10

ApplicantNobel Biocare AB
Decision Date2016-11-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IPS CaseDesigner is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K161634. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPS CaseDesigner?

IPS CaseDesigner is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Nobel Biocare AB. The 510(k) number is K161634.

When did IPS CaseDesigner receive FDA 510(k) clearance?

IPS CaseDesigner received FDA 510(k) clearance on 2016-11-10, under 510(k) number K161634.

Who is the listed applicant for IPS CaseDesigner?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPS CaseDesigner?

The FDA product code for IPS CaseDesigner is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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